Philips Ingenia 1.5T MRI systems recalled for patient support table installation defect
Philips is recalling 2,242 Ingenia 1.5T Magnetic Resonance Systems due to potential incorrect installation of the patient support table floor plate.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for a potential installation defect in the patient support table of a medical imaging system. The source text does not report any illnesses or injuries, and the hazard is potential rather than confirmed. However, it represents a risk-of-harm situation, which qualifies as High severity.
Plain-English summary
Philips North America LLC is recalling Ingenia 1.5T Magnetic Resonance Systems (MRI systems) used in medical facilities. The recall affects approximately 2,242 systems that were distributed worldwide.
The patient support table floor plate may be incorrectly installed in some systems. Philips is conducting this recall to address the potential installation defect.
The affected systems were distributed globally, including throughout the United States and internationally to numerous countries.
Healthcare facilities should contact Philips or their medical equipment provider to verify proper installation of the patient support table floor plate.
The recalled product
- Product
- Ingenia 1.5T, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 2,242
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 781396
- 781315
- 782115
- 781341
- 782101
- UDI-DI 884838055322
- 884838099715
- 884838099043
- 884838098275
- Serial No. Serial Number
- 70051
- 84508
- 84243
- 41044
- 84400
- 84537
- 41569
- 41104
- 41203
- 41195
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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